Browse Device Recalls

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 5,543 FDA device recalls.

Clear
DateProductReasonClassFirm
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211A A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W ... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DY... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) AAA CDS, REF CDS9840... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) BASIC NASAL, REF D... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ90500... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 22, 2024 Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET... A slight dimensional variation which has the potential for increased difficulty fitting into oute... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 20, 2024 3M Durapore Surgical Tape, Catalog Number 1538-118 Select lots of the 3M Durapore Surgical Tape, Catalog Number 1538-118, were incorrectly labeled w... Class II 3M Company - Health Care Business
Mar 15, 2024 Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Sym... Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit... Class II Covidien LP
Mar 15, 2024 Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 9119... Elekta has become aware that Disposable Biopsy Needles (911933) from one batch (837838839) can co... Class I Elekta Instrument AB
Mar 15, 2024 Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 1... Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit... Class II Covidien LP
Mar 14, 2024 Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STE... Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. Class II Merit Medical Systems, Inc.
Mar 14, 2024 Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STER... Their is a potential that sheaths labeled with .018 dilators may contain a .038 dilator. Class II Merit Medical Systems, Inc.
Mar 13, 2024 Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Numb... Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing pro... Class II Biomet, Inc.
Mar 12, 2024 ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Co... Product incorrectly labelled. Class II DePuy Orthopaedics, Inc.
Mar 5, 2024 Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Numb... Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after th... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 5, 2024 Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b)... Medline is recalling certain lots of our Adult Portable Bed Rails that were manufactured after th... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 4, 2024 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... The expiration date was not printed on the outer shipping label, leading to expired syringes bein... Class III Avanos Medical, Inc.
Mar 4, 2024 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... The expiration date was not printed on the outer shipping label, leading to expired syringes bein... Class III Avanos Medical, Inc.
Mar 4, 2024 NEOMED* Pharmacy Syringes - Nonsterile (Non ENFit) with below product descrip... The expiration date was not printed on the outer shipping label, leading to expired syringes bein... Class III Avanos Medical, Inc.
Mar 1, 2024 VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Ca... Potential for positively biased results due to signal reduction over shelf life. Class II Ortho-Clinical Diagnostics, Inc.
Mar 1, 2024 Medline medical procedure kits, labeled as follows: a) PARACERVICAL PUD TR... Trumpet Needle Guide ring can detach when excessive pressure is applied. Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Pro... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Curette kits labeled as: a) STERILE BUCK EAR CURETTE "00" (25697)... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP,... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion manual surgical kits labeled as: a) ST. VIRTUS SPLINTER FORCEP 6"... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product ... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Pr... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Forcep kits labeled as: a) STERILE F/P SPLINTER FORCEP (SF6141), P... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a uniq... Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for l... Class II Magellan Diagnostics, Inc.
Feb 23, 2024 Centurion hook kits labeled as: a) STERILE SKIN HOOK FINE (EA3975F), Product... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", P... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), ... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST718... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 23, 2024 Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (S... Product may have a weak seal which may result in a breach of sterility of the contents if the sea... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 21, 2024 HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H. It was discovered through a customer complaint that mislabeled product was distributed. Puritan d... Class II Puritan Medical Products Company, Llc
Feb 21, 2024 ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. The reason for the recall is the failure of calibration and quality controls due to a manufacturi... Class II Abbott Laboratories
Feb 20, 2024 HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100) Product was mislabeled as a Surgical Cap at its dispenser level. Class III O&M HALYARD, INC.
Feb 7, 2024 Access Substrate, REF 81906, For use with the Access Immunoassay Systems On 07 February 2024 Beckman Coulter made the decision to conduct a field action on Access Substra... Class II Beckman Coulter, Inc.
Feb 7, 2024 Medtronic DLP Vessel Cannula, Model Number REF 30000 Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP V... Class II Medtronic Perfusion Systems
Feb 6, 2024 SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the corr... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 6, 2024 SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the corr... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 6, 2024 SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the corr... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 6, 2024 SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented Due to two complaints, has come to our attention that additional guidance is required on the corr... Class II Waldemar Link GmbH & Co. KG (Mfg Site)
Feb 2, 2024 BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for ... Pack and pouch label is missing the manufacturing and expiration date. Class II Beaver Visitec International, Inc.
Jan 26, 2024 I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 75mm,Part Number S65 ST175 This Field Action is being conducted following the identification of a batch mix-up between I.B.S... Class II In2Bones, SAS

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.